The following data is part of a premarket notification filed by Norfolk Medical with the FDA for Omegaport Subcutaneously Implanted Drug Delivery.
| Device ID | K905646 |
| 510k Number | K905646 |
| Device Name: | OMEGAPORT SUBCUTANEOUSLY IMPLANTED DRUG DELIVERY |
| Classification | Port & Catheter, Implanted, Subcutaneous, Intravascular |
| Applicant | NORFOLK MEDICAL 7307 N. RIDGEWAY Skokie, IL 60076 |
| Contact | Michael J Dalton |
| Correspondent | Michael J Dalton NORFOLK MEDICAL 7307 N. RIDGEWAY Skokie, IL 60076 |
| Product Code | LJT |
| CFR Regulation Number | 880.5965 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-12-17 |
| Decision Date | 1991-03-27 |